LivingGLP1
Study S001106

Combined Active Treatment in Type 2 Diabetes With NASH

Registration

Registration
NCT04639414
Acronym
COMBAT_T2_NASH
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE4
Masking
TRIPLE
Status
COMPLETED
Enrollment
192
Start
2021-03-26
Primary completion
2025-01-31
Lead sponsor
German Diabetes Center
Conditions
Type 2 Diabetes; Non-alcoholic Steatohepatitis (NASH); Non-alcoholic Fatty Liver Disease (NAFLD)
Interventions
DRUG:Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector; DRUG:Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide; DRUG:Placebo matching empagliflozin and placebo pen injector matching semaglutide
Results posted
FALSE
Individual participant data sharing
NO
Secondary identifiers
EUDRACT_NUMBER:2019-001987-31; NIH:2019

Registered primary outcomes

  • Histological resolution of NASH without worsening of fibrosis [from baseline to 48 weeks]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0040528From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis
Manik Aggarwal, Clinical Liver Disease
2023OtherPMID 36938314DOIcites ClinicalTrials.gov:NCT04639414